Extracorporeal Shock Wave Therapy of Fasciitis Plantaris with the Piezoson 300

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1 Extracorporeal Shock Wave Therapy of Fasciitis Plantaris with the Piezoson 3 A. Betthäuser, K. Raabe Department of Orthopaedics, Allgemeines Krankenhaus Barmbek Head of Department Prof. Dr. E. Hille Rübenkamp 148, 2237 Hamburg 1. Introduction Plantar fasciitis is a common disorder. The success rates of conservative therapy such as physiotherapy, the use of inserts or orthotics and medical anti-inflammatory therapy is unsatisfactory. In publications in recent years, the effectiveness of ESWT in plantar fasciitis has been demonstrated only with devices that generate the energy electrohydraulically or electromagnetically (Rompe 1996a, Sistermann 1998, Buch 1999). Alternatives to ESWT in the treatment of plantar fasciitis include infiltration therapy and surgical therapy such as fasciotomy or heel spur resection, although the surgical techniques are associated with a higher complication rate (Davis 1994, Lester 1984, Schepsis 1991, Wolgin 1994). The aim of this study is to demonstrate the efficacy of ESWT in plantar fasciitis with the Piezoson 3. The Piezoson 3 generates shock wave energy piezoelectrically. We hope to show that the use of the Piezoson 3 results in a significant reduction of pain during normal daily routine and in clinical tests. 2. Materials and Methods The inclusion criteria were: Age between 18 and 75 years and a minimum of six months of unsuccessful conservative therapy with adequate use of inserts and at least two forms of therapy such as cryotherapy, local anti-inflammatory medication and/or corticosteroids, systemic antiinflammatory medication and/or corticosteroids, acupuncture, electrotherapy, ultrasound therapy, friction massage. Exclusion criteria were: Pregnancy, tumours, blood coagulation disorders or anticoagulant therapy, infections, pacemakers, epilepsy, arthritis in the vicinity of the plantar fascia, previous surgical treatment of the plantar fascia. 44 patients were included in the prospective study. The group included 23 women and 21 men with an average age of 53.8 (34-74) years. Patient data: Total: n = 44 Women: n = 23 Men: n = 21 Average age: 53.8 years Average height: 172 cm Average weight: 81 kg In 43 % of cases, only the right heel was affected, in 21 % the left heel and in 36% both heels. value Distribution 36 % 43 % 21 % Graphic 1: Location of the plantar fasciitis right Prior to treatment each patient was clinically examined, a lateral X-ray was available in all cases and the sonographic scans of the origin of the plantar fascia in two planes and in both feet were made with a 7.5 MHz linear scanner (SonoDIAGNOST 36, manufacturers. Philips, Hamburg). left both ESWL / ESWT

2 The prelocation to identify the thickest part of the ligament was performed with the same sonic head directly prior to therapy. The shock wave treatment was performed with the patient in the prone position with the lower leg supported by a rolled cushion. Local anaesthesia with 5 ml of Scandicain 1 % was necessary in only 5 % of the sessions. Treatment was performed with the Piezoson 3 from the firm of WOLF, Knittlingen. The Piezoson has an inline ultrasound location system with a 7.5 MHz sector scanner. The point at which the ligament was thickest was relocated sonographically, now with the sector scanner integrated in the therapy head and the target cross set to the focus filling the dome of the coupling membrane as far as possible. Ultrasound diagnosis gel was used as the coupling medium. Although the scanner integrated in the therapy head was retracted, the focus zone could also be observed during the therapy (the image is marginally less sharp than with the scanner extended, but is nevertheless perfectly adequate). During the therapy, the target cross position could therefore be monitored sonographically in two planes and adjusted when necessary. During each treatment, the position of the heel was changed slightly three times under the therapy head, so that an area of one square centimetre could be treated under permanent sonographic control. Immediately following the treatment, light compression was applied manually for one minute. The patients were treated on average 2.7 (2-4) times. The average interval between the individual sessions was 13 days. Each patient received an average of 5612 shock waves (2-8). The energy density was.24 (.2-.28) mj/mm 2, the frequency was 4 Hz. Patients were permitted to put full strain on the foot immediately treatment, a concomitant therapy such as reduced activity or rest was not prescribed. Patients continued to wear inserts. Follow up was three months the last shock wave therapy. Evaluation was based on the following criteria: 1. Distance walking painlessly without shoes 2. Distance walking painlessly with shoes 3. Visual analogue scale () pain on plantar pressure 4. pain intensity at rest 5. pain intensity during the night 6. pain intensity when walking During the longitudinal scan, the information provided by the patient immediately prior to the first therapy session and the information three months the last session was statistically compared. The visual analogue scale () ranged from value (no pain) to 1 (worst imaginable pain). The patients estimated the value during each of the tests listed above themselves and their estimates were logged. The statistical evaluation included, among other things the calculation of the mean value, median, minimum and maximum, standard deviation and significance test using the WILCOXON paired signed rank test and the KOLMOGOROV-SMIRNOV test. The dependent variables of the visual analogue scale were tested. 3. Results In all cases, there was a significant increase in Ithe distance that could be walked painlessly (see Figures 2 and 3). Comparison of distance walked painlessly with shoes per cent >1 metres <1 metres metres Graphic 2

3 Comparison of distance walked painlessly without shoes per cent Graphic >1 metres <1 metres metres 9 1 8, 6, 4, 2, Graphic 5 Pain intensity during the night 2,1,5 The significance of the two comparisons was checked using the Wilcoxon paired signed rank test. This revealed that both with and without shoes there was a significant increase in the distance that could be walked without pain (p<.1). The following figures 4-6 show the reduction of pain at rest, during the night and when walking. Graphic 7 shows the improvement in the pain caused by pressure. Once again the statistical analysis of the data shows a significant (p<.1) reduction in pain. The distribution columns represent the maximum and minimum values around the mean value. 1 8, 6, 4, 2, Graphic 6 Pain intensity when walking 7,9 1,8 Pain intensity at rest Pain intensity caused by pressure 1 1 8, 8, 7,5 6, 5,9 6, 4, 2,,3 4, 2, f 2,2 Graphic 4 Graphic 7

4 Following the individual ESWT sessions, 82 % of the patients initially reported a brief, painless period often followed by a phase of approximately one week of increased pain. Following this, there was a clear reduction in pain to a level below the initial level. The subjective palliative effect ranged from complete freedom of pain to a slight improvement. A long-term worsening of the pain was not observed in any case. No complications occurred. Some patients reported a shift in the point of maximum pain at rest, usually towards the lateral and dorsal edge of the foot. In these cases, it was necessary to shift the therapy centre according to the information provided by the patient (trigger point control). In the subsequent follow-up examinations 81 % of the patients found the treatment method very good or good and would undergo the treatment again. The sonographic appearance of the plantar fascia did not change initially following ESWT. After three months, a slight reduction of the thickening could be seen compared with the contralateral ligaments and with the initial findings. In no patient was it possible to find a correlation between the pain intensity and the size and shape of the bony heel spur. In keeping with this finding, the bony heel spur could be recognised unchanged on the mediolateral plain film of the heel during the follow-up examination. 71 % of the patients were still wearing their inserts when they returned for the follow-up examination. The reason given three months ESWT was the worry that the pain would return. 4. Discussion The study presented here shows that ESWT therapy of piantar fasciitis with the PIEZOSON 3 was successful in the reduction of pain and the maximum distance that could be walked without pain. The treatment was indicated only all conservative treatment methods had been tried prior to ESWT and that the only other alternative would be surgery. ESWT is then preferable to a surgical operation due to the lower complication rates. Compared with the literature (Haist 1996, Rompe 1996a, Rompe 1996b, Krischek 1998, Buch 1999) our study achieved similar short-term results in both in the influence of pain and in the degree of pain reduction. The distance that could be walked without pain with and without shoes improved more than ten-fold. On the visual analog scale (), the mean pain on pressure was reduced in the clinical tests from 7.5 to 2.2 following ESWT. The pain experienced during walking was reduced on this scale from 7.9 to 1.8. As with other authors, there were no relevant complications although in contrast to Rompe, we did not perform the procedure under local anaesthesia. Buch (1999) compared various parameters such as low and high energy therapy. The high-energy therapy was also used in this study. Neither the radiologically nor sonographically established size of the bony heel spur had any effect on the prognosis or the extent of the fasciitis. No change in the shape of the spur could be detected therapy. This fact strongly suggests that it is not the heel spur but rather the plantar fasciitis that is the primary cause of the painful symptoms. On the other hand, no significant, fast reduction in the thickening of the ligament following ESWT could be observed. Only a longer period from approximately eight weeks onwards was it possible to detect a reduction in the thickening and an increased echogeneity in the sonogramme. Such a slow adaptation must, however, be expected with all bradytrophic tissue. In contrast to X-ray location systems, the inline ultrasound location used in the method described here is capable of focusing the target structure, the origin of the plantar fascia, directly and allows observation during therapy. Prior to ESWT, the entire area of the origin of the plantar fascia was subjected to low intensity shock waves. In 9 % of cases, the point of maximum pain indicated by the patients (the trigger point) was at the point of maximum distension of the ligament. This trigger point localisation method was not reliable when local anaesthesia was administered previously or when therapy was started at the therapeutic intensity since presumably a gate control mechanism soon reduced pain at the focus point. If there was a discrepancy between the point of maximum ligament distension and the indicated trigger point, this was generally dorsal to the maximum ligament distension; in other words, in the direction of the bony insertion area.

5 We examined test subjects with healthy plantar fascia using the above method. At low ESWT intensity applied over the entire area of the origin, in all eight cases the slight pain induced was located extremely dorsal in the area of the bone ligament transition. From this, we conclude that the "trigger point location method" without prior local anaesthesia and at the beginning of the therapy appears to be a 9 % reliable localisation method for the initial adjustment of the therapy head. 5. Conclusions The application of piezoelectrically generated shock wave therapy in plantar fasciitis results in a statistically significant (p<.1) reduction of spontaneous pain and exercise induced pain and the significant increase in the distance that can be walked in a short-term follow-up period. Whether this reduction in pain is achieved over a long term must be investigated in further studies with longer follow-up periods. Although the absence of complications and the efficacy of the procedure as shown in this study are promising, the therapy costs are higher and the development of an ESWT unit with localisation based on the trigger point method following initial sonographic localisation would be desirable. Initially, such a unit made much less expensive by the absence of integrated ultrasound location could be used for indications that require neither local anaesthesia nor the covering of a larger focus zone during on session. Ideal candidates for such a unit are plantar fasciitis and patellar ligament tendinitis.

6 6. Literature Buch M, Hahne H, Träger D, Siebert W: Die Stoßwellentherapie des Fersensporns - Einfluss verschiedener Parameter auf das Therapieergebnis. Ortho.Prax.35 (1999) Davis TF, Severud E, Baxter DE: Painful heel syndrome: results of nonoperative treatment. Foot Ankle Int. 15 (1994) Haist JD, von Keitz-Steeger D: Shock wave therapy in the treatment of near to bone soft tissue pain in sportsmen. int. J. Sports med. 17 (1996) Heller KD, Niethard FU: Der Einsatz der extrakorporalen Stoßwellentherapie in der Orthopädie - eine Metaanalyse. Z.Orthop.136 (1998) Krischek O, Rompe JD, Herbsthofer B, Nafe B: Symptomatische niedrig-energetische Stoßwellentherapie bei Fersenschmerzen und radiologisch nachweisbarem plantarem Fersensporn. Z.Orthop. 136 (1998) Lester DK, Buchanan JR: Surgical treatment of plantar fasciitis. Clin. Orthop. 186 (1984) Rompe JD, Hopf C, Nafe B, et al.: Low Energy extracorporal shock wave therapy for painful heel: a prospective controlled single blind study. Arch. Orthop. Trauma Surg. 115 (1996a) Rompe JD, Küllmer K, Eysel P, Riehle HM, Bürger R, Nafe B: Niedrigenergetische extrakorporale Stoßwellentherapie (ESWT) beim plantaren Fersensporn. Orth. Prax.32 (1996b) Schepsis AA, Leach RE, Gorcyca: Plantar fasciitis: Etiology, treatment, surgical results and review of the literature. Clin. orthop. 266 (1991) Sistermann R, Katthagen BD: 5 Jahre Lithotripsie des plantaren Fersenspornes: Erfahrungen und Ergebnisse Eine Nachuntersuchung nach 36,6 Monaten. Z. Orthop. 136 (1998) Wolgin M, Cook C, Graham C, et.al.: Conservative treatment of plantar hell pain: long term follow-up. Foot Ankle Int. 15 (1994) 97-12

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